FDA.reportPublic FDA data

Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Group B beta-haemolytic Streptococcus bacteria in a clinical specimen.
GUDID devices
12
Last updated
2024-09-04 08:34:27

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03610522384389Exact DiagnosticsEXACT DIAGNOSTICS, LLC120200692024-08-27
15420045510906Panther Fusion®Hologic, Inc.KIT, GBS CONTROLS, FUSION, IVD2019-07-30
10634853001265Inocu SwabsMICROBIOLOGICS INC.GBS-012022-09-26
70845357044180QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.82422022-09-01
70845357044197QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.82582022-09-01
01220000260146NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Group B Streptococci Positive Control2020-10-16
01220000260153NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Group B Streptococci Negative Control2020-10-16
00840733101311illumigene Group B Streptococcus External Control KitMERIDIAN BIOSCIENCE, INC.2799002016-09-23
00840733102110Alethia™ Group B Streptococcus External Control KitMERIDIAN BIOSCIENCE, INC.4799002019-01-08
20816101025651Simplexa™ GBS Positive Control PackDIASORIN MOLECULAR LLCMOL35602018-11-20
30014613311164Quidel MolecularDIAGNOSTIC HYBRIDS, INC.M1162018-11-16
70845357041219QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.8194 Cepheid Xpert® GBS LB Control Panel2019-01-31